31 results · 24ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

NAWALUTION SKIN AND WOUND CLEANSER

FDA 510(k)
FDA Unclassified ·Unknown

Biomet® Knee System

FDA UDI
Biomet Orthopedics, LLC·00880304006829·

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X1416600·14mm H x 16mm W x 60mm L x 0 degrees XLIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X141660120·14mm H x 16mm W x 60mm L x 12 degrees XLIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587L141660120·14mm H x 16mm W x 60mm L XLIF Trial 12 degree L...

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X14166080·14mm H x 16mm W x 60mm L x 8 degrees XLIF

TRIMEDYNE HOLMIUM LASER SYSTEMS

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD ULTRA-FINE INSULIN SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·September 16, 2019

Matrixx System

FDA UDI
NEXXT SPINE, LLC·00889929065402·Corpectomy, 14Dx16Wx60H 0°

Matrixx System

FDA UDI
NEXXT SPINE, LLC·00889929038956·Corpectomy, 14Dx16Wx60H 6°

PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

FDA Adverse Event
Injury ·BIOMET, INC.·Product code JDI·October 4, 2023

PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

FDA Adverse Event
Injury ·BIOMET, INC.·Product code JDI·October 4, 2023

PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

FDA Adverse Event
Injury ·BIOMET, INC.·Product code JDI·October 4, 2023

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

ACCU-CHEK ® AVIVA TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 27, 2011

PKG, ALLIS FORCEPS, P/N 0250080240. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·December 24, 2014

MAXIM KNEE SYSTEM -FML AUG BLT 65X10ML/LR

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·March 22, 2017

AGC TOTAL KNEE PROSTHESIS - INTLK FMRL 65 RT

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JWH·March 22, 2017